Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish
- Conditions
- Dental Caries in Children
- Interventions
- Drug: Silver Diamine FluorideDrug: Sodium Fluoride Varnish
- Registration Number
- NCT03557996
- Lead Sponsor
- Cairo University
- Brief Summary
To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.
- Detailed Description
The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation.
Benefit to the patient
* No pain and infection.
* Enhance child cooperation.
* Enhance better patient compliance.
* Decrease cost of dental treatment and may eliminate the need for General Anesthesia.
Benefit to the dentist
* Develop an effective fast easy method to arrest the caries by using SDF.
* Ease of dental treatment.
* Better cooperation with the child.
* The procedure is simple.
* Inexpensive and non-invasive.
* It does not require expensive equipment or support infrastructure, such as pipe water or electricity.
Benefit to the population
* Reduce the harmful impact of oral health problems in preschool children from low income families.
* SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities.
Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
- Children with carious primary teeth before eruption of permanent teeth
- High caries risk patients with anterior or posterior carious lesions
- Uncooperative children without access to or with difficulty accessing dental care.
- Children with spontaneous or elicited pain from caries
- Tooth mobility
- Signs of pulpal infection
- Severe medical conditions that would not allow management in the clinic
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Silver Diamine Fluoride 38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid Group 2 Sodium Fluoride Varnish 5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12
- Primary Outcome Measures
Name Time Method Discoloration 12 months Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)
- Secondary Outcome Measures
Name Time Method Timing of discoloration 12 months Visual examination at follow up
Postoperative Pain: Questioning the patient 12 months Questioning the patient and/or the parentBinary (yes or No)
Investigator reported discoloration 12 months Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination
Caries arrest (dentine texture) 12 months Caries arrest will be assessed through tactile examination (Soft or hard) Tactile examination
Parental satisfaction: Questioning the parent 12 months Questioning the parent
Trial Locations
- Locations (1)
Pediatric Dentistry, Faculty of Dentistry, Cairo University
🇪🇬Cairo, Egypt